PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Topics Reviews
Points to Consider for Virus and DNA Removal Processing using Membranes during the Scale-up of Biopharmaceutical Drug Development
Masahiro ODA
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2002 Volume 4 Issue 1 Pages 26-34

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Abstract
   Development of biopharmaceutical products can be accelerated by proper selection and application of membranes used during product and process development. This Report will discuss scalability, active product transmission and, filterability focusing on virus removal and DNA removal. Also, it will describe, how proper selection of test filters can eliminate or reduce further testing at pilot and production scales, thus reducing time to submission and marketing of the drug product.
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© 2002 Parenteral Drug Association Japan Chapter
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